Dear all,
In accordance with the provisions established in the Salvadoran Technical Regulation (RTS 11.03.04:23) (see ATTACHED communication), we hereby make a KIND REMINDER to proceed with scheduling the submission of the quarterly report, as required by section 5.8.2 of said RTS, since submission must be carried out within the first 10 business days of April.
The applicable forms for this Quarterly Report are ATTACHED for your reference.
Quarterly reports:
- Report non-serious events and incidents for which causality related to the medical device has been determined.
- In case NO adverse events or incidents occur during the established period, SUBMIT A ZERO REPORT.
- Units that submit zero reports for THREE CONSECUTIVE QUARTERS must design and submit to the Superintendence of Health Regulation (SRS) a PLAN TO INTENSIFY THE SEARCH FOR ADVERSE EVENTS AND INCIDENTS.
- The quarterly report to be submitted must include only adverse events and incidents that occurred in El Salvador and are related to medical devices; therefore, events occurring abroad must not be included in this report.
Below are the REPORTING DEADLINES:
| QUARTER | PERIOD | REPORT SUBMISSION |
| I | January 1 to March 30 | First 10 business days of April |
| II | April 1 to June 30 | First 10 business days of July |
| III | July 1 to September 30 | First 10 business days of October |
| IV | October 1 to December 31 | First 10 business days of January of the following year. |
We appreciate your kind attention and remain awaiting your comments.
Kind regards,